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Maxillary SinusitisPhase 3NCT00537563

AMS VS MOXI Ketek vs Avelox in AMS

A Phase 3 study testing Telithromycin in people with Maxillary Sinusitis, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure visit, and to assess the safety of telithromycin given once daily for 5 days vs moxifloxacin given once daily for 10 days in the treatment of subjects with AMS. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Maxillary Sinusitis
What is being tested?
Telithromycin
How many people
351 participants
Where
1 siteUnited States
Study dates
Dec 2002to Sep 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects, aged 18 years or older, AMS diagnosed (clinically and radiologically) who were willing to undergo rhinoscopic aspiration or deep nasal swab at the baseline/pre-therapy visit. Female subjects of childbearing potential were required to have a negative pregnancy test before undergoing any study procedure and to use an accepted contraceptive method during the study.

Who cannot join

  • Women who were breast-feeding or pregnant, as demonstrated by serum or urine pregnancy tests carried out before exposure to study medication or the start of any study procedure that could pose a risk to the fetus;
  • Subjects with a history of recurrent sinusitis (defined as more than 3 episodes of sinusitis that required antibiotic therapy in the preceding 12 months);
  • Subjects with a history of chronic sinusitis (defined as symptoms lasting greater than 28 days);
  • Subjects with sphenoidal sinusitis involvement that required treatment other than oral antibiotics;
  • Subjects with nosocomial-acquired sinusitis within 2 weeks (eg, hospitalization or nonambulatory, institutional confinement, including nursing homes);
  • Subjects with any concomitant medication [including functionally significant, major obstructive anatomical lesions likely to impair resolution of infection (eg, nasal polyps extending past the middle turbinate, tumor, or severe septal deviation)], such as: asthma, cystic fibrosis, immotile cilia syndrome, prior nasopharyngeal or sinus surgery, sinus polyps, clinically relevant cardiovascular (eg, congestive heart failure), neurologic, endocrine, or other major systemic disease that could have made implementation of the protocol or interpretation of the study results difficult;
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  • Subjects with a need for immediate surgery for maxillary sinusitis;
  • Subjects who used nasal, nasogastric, or nasotracheal catheters;
  • Subjects with previous sinus surgery within the past 6 months or sinus lavage within the past 7 days;
  • Subject who were long-term (> than or = to 4 weeks) users of nasal decongestants like oxymetazoline 0.05%;
  • Subjects with suspected nonbacterial infections;
  • Subjects with a concomitant odontological infection that would require antibiotic therapy or surgery;
  • Subjects with unknown or suspected hypersensitivity to, or a known or suspected serious adverse reaction to either study medication, any fluoroquinolone, or any macrolide antibiotic;
  • Subjects who would likely have required on-study treatment with drugs known to have contraindicated drug interactions with either study medication and/or macrolides or fluoroquinolones in general, including, but not limited to: ergot alkaloid derivatives, cholinesterase inhibitors (eg, tacrine, donepezil, physostigmine) ketamine, carbamazepine, St John's Wort, Class IA (eg, quinidine, procainamide), or Class III antiarrhythmic agents (eg, amiodarone, sotalol);
  • Subjects who required anticoagulant therapy (eg, warfarin);
  • Subjects who received treatment with other systemic antibiotics (oral or parenteral) within 14 days prior to study enrollment;
  • Subject who received moxifloxacin or another fluoroquinolone antibiotic for this infectious episode;
  • Likelihood of required treatment during the study period with drugs not permitted by the protocol;
  • Treatment with any investigational product in the last 1 month prior to study entry;
  • Subjects with a progressively fatal disease; life expectancy <less than or = to 3 months;
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult;
  • History of drug or alcohol abuse;
  • Impaired hepatic function [as shown by previous clinical laboratory values of AST (SGOT) and/or ALT (SGPT) > than or = to 3 times the upper limit of reference range, total bilirubin > than 2 times the upper limit of reference range (except for Gilbert's disease), encephalopathy, etc];
  • Impaired renal function [as shown by previous clinical laboratory values of creatinine clearance < than or = to 30 mL/min (< than or = to 0.50 mL/sec), serum creatinine > than or = to 2.0 mg/dl (> than or = to 176 micromol/L), etc]. Creatinine clearance may have been estimated by formula or by nomogram;
  • Immunocompromised subjects, such as subjects with HIV infection and who had either an AIDS-defining condition (eg, Kaposi's sarcoma and Pneumocystis carinii pneumonia), or a CD4 + T-lymphocyte count of < 200/mm3). A complete list is provided in Appendix 3 of the clinical study protocol (see @@Appendix A.1.1).
  • subjects with neutropenia (<1500 neutrophils/mm3) not attributable to the acute infectious disease
  • subjects with metastatic or hematological malignancy
  • splenectomised subjects with known hyposplenia or asplenia
  • subjects with known IgG deficiency
  • Subject with known long QT syndrome or familiar history of long QT syndrome (if no previous ECG has invalidated this risk factor), or personal history of coronary disease, ventricular arrhythmia, bradycardia < 50 beats/min, or known uncorrected hypokalemia or hypomagnesemia, or who were treated with concomitant medication known to prolong QT interval (eg, cisapride, pimozide, astemizaole, terfenadine, or potent CYP3A4 inhibitors, such as: protease inhibitors, ketoconazole);
  • Mental condition that rendered the subject unable to understand the nature, scope, and possible consequences of the study;
  • Subjects diagnosed with myasthenia gravis (ie, Protocol Amendment No. 1);
  • Subjects unlikely to comply with the protocol (eg, uncooperative attitude, inability to return for follow-up visit, and unlikely to complete the study);
  • Subjects without a permanent residential address or home telephone number;
  • Any waiver of these inclusion/exclusion criteria was to be approved by the investigator and Aventis on a case-by-case basis, prior to study enrollment. This was to be documented by both the investigator and Aventis; or
  • No subject was allowed to enroll in this study more than once.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sanofi-Aventis

    Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure visit, and to assess the safety of telithromycin given once daily for 5 days vs moxifloxacin given once daily for 10 days in the treatment of subjects with AMS.

Being tested
Telithromycin
Medical subject headings
Maxillary Sinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelithromycinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate equivalence in clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure (TOC) visit.

    Measured: Days 17 to 24

Secondary outcomes (1)

  1. Assess the safety of telithromycin given once daily for 5 days vs moxifloxacin given once daily for 10 days in the treatment of subjects with AMS.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2007 (estimated)
  2. Study startDec 2002
  3. Primary completionSep 2003
  4. Study completionSep 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00537563
Sponsor's protocol ID
HMR3647A_4017
Status last verified
Feb 2012
First submitted
28 Sep 2007
Last updated
17 Feb 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telithromycin in people with Maxillary Sinusitis, run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate equivalence in clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure (TOC) visit. (time frame: Days 17 to 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00537563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.

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